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Merck KGaA v. Integra Lifesciences I, Ltd.

Supreme Court of the United States · Civil Procedure

Civil ProcedurePatent lawFDA regulatory safe harbor35 U.S.C. § 271(e)(1)patent infringementsafe harborpreclinical researchIND

Facts

Respondents owned patents covering RGD peptides, and Merck funded Scripps research using Merck-supplied RGD peptides to evaluate their suitability as anti-angiogenesis drug candidates. From 1995 to 1998, Scripps conducted in vitro and in vivo experiments on several peptide candidates to measure efficacy, specificity, toxicity, mechanism of action, and pharmacokinetics, ultimately selecting one candidate as the most promising for human testing. Merck later initiated a formal regulatory project and discussed the selected candidate with FDA officials. Respondents sued, alleging that supplying and using the patented peptides in these experiments infringed their patents.

Issue

Whether § 271(e)(1) exempts from patent infringement preclinical uses of patented inventions when the research is aimed at developing information relevant to FDA approval, even if the particular experiments or compounds are not ultimately included in an FDA submission. More specifically, the question was whether preclinical studies not themselves submitted to the FDA, or involving compounds not ultimately the subject of an IND or NDA, can still fall within the statutory safe harbor.

Rule

Section 271(e)(1) exempts from infringement all uses of patented inventions that are reasonably related to the development and submission of any information under federal law regulating drugs. The exemption includes preclinical studies when there is a reasonable basis for believing that the patented compound may work through a particular biological process to produce a particular physiological effect, and the research, if successful, would be appropriate to include in an FDA submission. The safe harbor is not limited to clinical trials, to data actually submitted to the FDA, or to experiments on a compound that ultimately becomes the subject of an FDA application.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

North Harbor Biologics in Boston licenses a patented peptide from no one and instead uses a competitor's patented peptide without permission in mouse studies for a possible stroke treatment. Its scientists have data suggesting the peptide may block a specific receptor involved in post-stroke inflammation, and they run preclinical studies measuring efficacy, pharmacokinetics, and mechanism of action to decide whether to pursue an IND.

If the patent owner sues for infringement, which is the strongest argument that the studies fall within the statutory safe harbor?

Explanation. The majority read § 271(e)(1) broadly to include preclinical studies, not just clinical trials. The key is whether the use is reasonably related to developing information for submission under federal drug law. That standard is satisfied where the drugmaker has a reasonable basis for believing the patented compound may work through a particular biological process to produce a particular physiological effect, and the research, if successful, would yield information appropriate for an IND or NDA. The Court specifically rejected limiting the safe harbor to safety studies, to post-IND work, or to clinical testing only. (Derived from Merck KGaA v. Integra Lifesciences I, Ltd. (n.d.).)